DIAPER RASH - zinc oxide cream
Navarro Discount Pharmacies,LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Zinc Oxide 40%

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps protect skin from wetness
helps prevent and temporarily protect chafed, chapped, cracked or windburned skin lips

Warnings

For external use only

Do not use

over deep or puncture wounds, infections or lacerations

When using this product

avoid contact with the eyes

Stop use and ask a doctor

if condition worsens or does not improve within 7 days.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

cleanse the diaper area
allow to dry
apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other information

store at room temperature

Inactive ingredients

Talc, Vacellin, Bees wax, Dimethicone, Liquid paraffin, Tocopherol acetate, Sesquioleate sorbitan, Aloe vera gel, Methylparaben, Propylparaben, Purified water

Package label

Vida Mia Diaper Rash Cream

DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59970-045
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (ZINC OXIDE)	ZINC OXIDE	0.40 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
TALC
APIS MELLIFERA
MINERAL OIL
TOCOPHEROL
SORBITAN SESQUIOLEATE
ALOE VERA LEAF
METHYLPARABEN
PROPYLPARABEN
WATER

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59970-045-04	1 TUBE ( TUBE) in 1 BOX	contains a TUBE
1		114 g in 1 TUBE	This package is contained within the BOX (59970-045-04)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/13/2012

Labeler - Navarro Discount Pharmacies,LLC (094930963)

Establishment
Name	Address	ID/FEI	Operations
Neopharm Co., Ltd.		631101883	manufacture

Revised: 07/2012 Navarro Discount Pharmacies,LLC